NCT00274651终止2 期
A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 15
- 主要终点
- Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))
研究概览
简要总结
Open-label, non-randomized trial to assess the effectiveness of PXD101 in patients with recurrent or refractory cutaneous or peripheral and other types of T-cell lymphomas. PXD101 is a new, potent histone deacetylase (HDAC) inhibitor. Patients are treated with belinostat(PXD101) 1000 mg/m2 on days 1-5 of a 21 day cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female with age > or = 18 years.
- •Histologically confirmed diagnosis of cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) or other T-cell non-Hodgkin's lymphoma (NHL).
- •Must have failed at least one line of prior systemic therapy. No limitation in number of prior therapies. CTCL patients who are refractory or intolerant to oral Targretin are also eligible.
- •The presence of measurable disease (defined as > or = 1 cm with radiographic imaging) for PTCL or stage 1B or greater disease for CTCL and assessable by the severity-weighted assessment tool (SWAT).
- •Adequate bone marrow and hepatic function including the following:
- •Absolute neutrophil count > or = 1,000 cells/mm3, platelets > or = 40,000/mm3
- •Total bilirubin < or = 1.5 x upper normal limit or < or = 3 x upper normal limit if hepatic involvement
- •AST (SGOT) (aspartate aminotransferase), ALT (SGPT) (alanine aminotransferase) < or = 2.5 x upper normal limit (< or = 5 x upper normal limit if hepatic involvement)
- •Hemoglobin > or = 9.0 g/dL.
- •Serum potassium within normal range.
- •Karnofsky performance status > or = 70%.
- •Estimated life expectancy > 3 months.
- •Signed informed consent approved by the Institutional Review Board (IRB).
排除标准
- •Anti-cancer therapies within 4 weeks of first PXD101 administration should be excluded unless toxicity from prior anti-cancer therapy has resolved or returned to baseline and cancer disease status warrants.
- •Any use of investigational drugs within 4 weeks prior to study registration.
- •Major surgery within 4 weeks of study drug administration.
- •Prior allogeneic bone marrow transplant.
- •A diagnosis of adult T-cell lymphoma/leukemia (ATLL) or precursor T-lymphoblastic lymphoma.
- •Co-existing active infection or any co-existing medical condition likely to interfere with trial procedures. However, patients with progressing CTCL whose open skin lesions are frequently infected may not be excluded from this trial at the discretion of Investigators.
- •Clinically significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension, and congestive heart failure related to primary cardiac disease, a condition requiring anti-arrhythmic therapy, history of sustained ventricular tachycardia, history of ventricular fibrillation or Torsade de Pointes, bradycardia (HR<50bpm) with or without a pacemaker, bifascicular block with a right bundle branch block and a left anterior block, ischemic or severe valvular heart disease, a myocardial infarction within 6 months or a left ventricular ejection fraction < 40% (by echocardiogram [ECHO] or multigated acquisition scan [MUGA]) within 3 months of study enrolment.
- •A marked baseline prolongation of QT/QTc ((corrected) QT) interval, e.g., repeated demonstration of a QTc interval > 450 milliseconds (msec). Long QT Syndrome; the required use of concomitant medication on belinostat infusion days that may cause Torsade de Pointes.
- •Renal insufficiency defined as a calculated creatinine clearance of < 45 mL/min/1.73 m
- •A history of allergic reactions attributed to compounds of similar chemical or biological composition to PXD101 and L-arginine.
- •Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
- •Patients requiring treatment for other malignant diseases or less than 5 years post-treatment completion for an invasive malignant disease (excluding non-melanotic skin cancers or cervical cancer in-situ). Patients with any history of melanoma should be excluded.
- •Pregnant or breast-feeding women, and women of childbearing age and potential, who are not willing to use effective contraception. Male patients and/or their fertile female partners who are not willing to use contraceptives during the trial.
- •Known infection with HIV, human T-cell leukemia virus type-1 (HTLV-1), hepatitis B or hepatitis C.
研究组 & 干预措施
Arm A
Experimental
PXD101 1000 mg/m2 once daily for 5 days every 21 days
干预措施: belinostat (Drug)
Arm B
Experimental
PXD101 1000 mg/m2 once daily for 5 days every 21 days
干预措施: belinostat (Drug)
结局指标
主要结局
Objective Response Rate in Patients With Recurrent or Refractory Peripheral T-cell Lymphoma (PTCL))
时间窗: throughout the study, or for a maximum of 2 years
Tumor response was assessed using the revised criteria of Cheson (Cheson 2007).Tumor assessments were done using conventional radiographic methods, e.g. CT or CT/PET.
Objective Response Rate in Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma (CTCL)
时间窗: throughout the study, or for a maximum of 2 years
Tumor response was assessed using Cheson (Cheson 2007) and SWAT criteria. The SWAT score represents the product of the percentage total body surface area (TBSA) involvement of each lesion type (patch, plaque, and tumor or ulceration), multiplied by a weighting factor.
次要结局
- Time to Progression(throughout the study, or for a maximum of 2 years)
- Duration of Response(throughout the study, or for a maximum of 2 years)
- Time to Response(throughout the study, or for a maximum of 2 years)
研究者
研究点 (15)
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